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Additional treatment to primary PCI: effects of ischemic postconditioning and Exenatide. - Hebe-2

Additional treatment to primary PCI: effects of ischemic postconditioning and Exenatide. - Hebe-2

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-011158-17-NL
Enrollment
280
Registered
2009-04-02
Start date
2009-08-20
Completion date
Unknown
Last updated
2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with a large myocardial infarction

Interventions

Trade Name: Byetta Product Name: exenatide Pharmaceutical Form: Suspension for injection

Sponsors

Erasmus MC
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Consecutive patients with a large Myocardial infarction are screened for inclusion in the trial. The eligibility criteria consist of the following: 1. Delay between onset of chest pain and PCI = 6 hours in case of inferiolateral wall infarction and = 12 hours in case of anterior wall infarction 2. Persistent ST-elevation on entry in the cath lab 3. Occluded (TIMI = 1) infarct related artery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Younger than 18 years of age 2. Chronic obstructive lung disease with evidence of bronchospasm 3. Concomitant use of dipyridamole / theophylline 4. Second/third degree heart block or sick sinus syndrome 5. Cardiogenic shock / post cardiac resuscitation 6. Thrombolytic therapy in the previous week 7. Pre-excisting heart failure 8. History of known previous myocardial infarction, CABG 9. Any contraindication for MRI, i.e.: 10. Serious known concomitant disease with a life expectancy of less than one year

Design outcomes

Primary

MeasureTime frame
Main Objective: The primary objective of this study is to determine whether ischemic postconditioning with or without pharmacological glycemic control is superior to the standard care given in PCI and whether these effects are acute or chronic.;Secondary Objective: VOLGT VOLGT;Primary end point(s): Infarct size measured on delayed enhance (DE) MRI at 4 months.

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026